A study on comparison of two different treatment schedules in brachytherpay for cervical cancer.
Phase 2
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
- Registration Number
- CTRI/2022/07/043863
- Lead Sponsor
- Dr Partha Sarathi Bhattacharyya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. All biopsy-proven Ca. cervix cases (squamous, adenocarcinoma, adeno-squamous histology) between the age of 18 to 70 years with Karnofsky Performance Status or above 70% will be considered.
2. Patients with carcinoma cervix Stage IIB – IIIB that underwent external beam radiotherapy (EBRT), irrespective of lymph node involvement that are fit for interstitial brachytherapy (ISBT) will be considered.
Exclusion Criteria
1. Diabetes mellitus (DM)
2. Chronic obstructive pulmonary disease (COPD),
3. Ischemic heart disease (IHD)
4. HIV+
5. HBsAg+
6. Prior malignancies
7. Mental illness
8. Patients unfit for epidural anesthesia
9. Pregnant and lactating women.
10. Renal dysfunction (S. creatinine >1mg/dl)
11. Hepatic dysfunction (S. bilirubin >1mg/dl)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ate toxicities according to Common terminology criteria for adverse events (CTCAE, version 5)Timepoint: Median 2 years of follow-up
- Secondary Outcome Measures
Name Time Method Survival <br/ ><br>Response rateTimepoint: median 2 years <br/ ><br>3rd and 6th month